Surgical Stapling and Cutting Device

ABSTRACT

A medical device, comprising a pistol-shaped handle, a laparoscopic shaft extending from the handle having a distal end and defining a shaft axis, a surgical end effector connected to the distal end of the shaft, a surgical procedure actuator operable to carry out a surgical procedure on tissue at the end effector, and a rotating knob at the handle that is rotatable with respect to the shaft about the shaft axis and is operable to actuate the surgical procedure actuator and effect the surgical procedure.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is:

-   -   a divisional of U.S. patent application Ser. No. 11/491,626,        filed on Jul. 24, 2006 (which application claims the priority,        under 35 U.S.C. §119, of U.S. Provisional Patent Application No.        60/702,643, filed on Jul. 26, 2005, U.S. Provisional Patent        Application No. 60/760,000, filed on Jan. 18, 2006, and U.S.        Provisional Patent Application No. 60/811,950, filed on Jun. 8,        2006);    -   a divisional of U.S. patent application Ser. No. 11/540,255,        filed on Sep. 29, 2006, now U.S. Pat. No. 7,404,508;    -   a divisional of U.S. patent application Ser. No. 11/541,105,        filed on Sep. 29, 2006;    -   a divisional of U.S. patent application Ser. No. 11/844,406,        filed on Aug. 24, 2007, now U.S. Pat. No. 7,419,080;    -   a divisional of U.S. patent application Ser. No. 12/139,142,        filed on Jun. 13, 2008;    -   a divisional of U.S. patent application Ser. No. 12/633,292,        filed on Dec. 8, 2009; and    -   a divisional of U.S. patent application Ser. No. 13/228,933,        filed on Sep. 9, 2011, the entire disclosures of which are        hereby incorporated herein by reference in their entireties.

FIELD OF INVENTION

The present invention lies in the field of medical devices, inparticular, in the field of surgical stapling instruments and methodsfor use thereof that are capable of applying lines of staples to tissuewhile cutting the tissue between those staple lines and, moreparticularly, to improvements relating to stapler instruments andimprovements in processes for forming various components of such staplerinstruments that include an articulating shaft. The device and methodscan be used, particularly, for stapling and cutting tissue duringendoscopic or laparoscopic surgical procedures.

BACKGROUND OF THE INVENTION

Endoscopic surgical instruments are often preferred over traditionalopen surgical devices because a smaller incision tends to reduce thepost-operative recovery time and complications. Consequently,significant development has gone into a range of endoscopic surgicalinstruments that are suitable for precise placement of a distal endeffector at a desired surgical site through a cannula of a trocar. Thesedistal end effectors engage the tissue in a number of ways to achieve adiagnostic or therapeutic effect (e.g., endocutter, grasper, cutter,staplers, clip applier, access device, drug/gene therapy deliverydevice, and energy device using ultrasound, RF, laser, etc.).

Positioning the end effector is constrained by the trocar. Generally,these endoscopic surgical instruments include a long shaft between theend effector and a handle portion manipulated by the clinician. Thislong shaft enables insertion to a desired depth and rotation about thelongitudinal axis of the shaft, thereby positioning the end effector toa degree. With judicious placement of the trocar and use of graspers,for instance, through another trocar, often this amount of positioningis sufficient. Surgical stapling and severing instruments, such asdescribed in U.S. Pat. No. 5,465,895 to Knodel et al., are an example ofan endoscopic surgical instrument that successfully positions an endeffector by insertion and rotation.

One stapler manufactured by United States Surgical Corporation anddescribed in U.S. Pat. Nos. 6,644,532 and 6,250,532 to Green et al. havean end effector that pivotally moves along a single plane in stepsdependent upon activation of a lever that correspondingly moves along asingle plane in similar steps. See FIGS. 31 and 32 therein. The U.S.Surgical Corp. stapler, however, is limited by the predetermined anglesthat it can achieve and by the limited side to side pivoting (−45degrees to +45 degrees) that requires two hands for operation.

Depending upon the nature of the operation, it may be desirable tofurther adjust the positioning of the end effector of an endoscopicsurgical instrument rather than being limited to insertion and rotation.In particular, it is often desirable to orient the end effector at anaxis transverse to the longitudinal axis of the shaft of the instrument.The transverse movement of the end effector relative to the instrumentshaft is conventionally referred to as “articulation.” This articulatedpositioning permits the clinician to more easily engage tissue in someinstances. In addition, articulated positioning advantageously allows anendoscope to be positioned behind the end effector without being blockedby the instrument shaft.

While the aforementioned non-articulating stapling and severinginstruments have great utility and may be successfully employed in manysurgical procedures, it is desirable to enhance their operation with theability to articulate the end effector, thereby giving greater clinicalflexibility in their use. Articulating surgical instruments generallyuse one or more firing bars that move longitudinally within theinstrument shaft and through the articulation joint to fire the staplesfrom the cartridge and to cut the tissue between the innermost staplelines. One common problem with these surgical instruments is control ofthe firing bar through the articulation joint. At the articulationjoint, the end effector is longitudinally spaced away from the shaft sothat the edges of the shaft and end effector do not collide duringarticulation. This gap must be filled with support material or structureto prevent the firing bar from buckling out of the joint when the singleor multiple firing bars is subjected to longitudinal firing loads. Whatis needed is a support structure that guides and supports the single ormultiple firing bars through the articulation joint and bends or curvesas the end effector is articulated.

U.S. Pat. No. 5,673,840 to Schulze et al. describes a flexiblearticulation joint that is formed from an elastomeric or plasticmaterial that bends at the flexible joint or “flex neck.” The firingbars are supported and guided through a hollow tube within the flexneck. The flex neck is a portion of the jaw closure mechanism and moveslongitudinally relative to the end effector, shaft, and firing bars whenthe jaws are closed on tissue. The firing bars then move longitudinallywithin the flex neck as the staples are fired and tissue is cut.

U.S. Pat. No. 5,797,537 to Oberlin et al. (owned by Richard-AllanMedical Industries, Inc.) describes an articulation joint that pivotsaround a pin, rather than bends around a flex joint. In this instrument,firing bars are supported between a pair of spaced support platesconnected at one end to the shaft and at another end to the endeffector. At least one of those connections is a slidable connection.The support plates extend through the articulation joint adjacent to theflexible drive member in the plane of articulation such that the supportplates bend through the gap in the plane of articulation and theflexible firing bar bends against the support when the tip isarticulated in one direction from its aligned position. U.S. Pat. No.6,330,965 to Milliman et al. from U.S. Surgical teaches the use ofsupport plates that are fixedly attached to the shaft and slidablyattached to the end effector.

Although these known support plates guide a firing bar through anarticulation joint, it is believed that performance may be enhanced. Forinstance, it is often desirable for the firing bar to be rapidlyaccelerated during firing to ensure sufficient momentum for severingtissue effectively. Rigidly attached support plates may tend to dislodgein response, allowing the firing bar to blow out from the articulationjoint. As a further example, it is desirable for the instrument tooperate in the same manner whether articulated or not. Increasedfriction when articulated would be inconvenient and distracting to theclinician if required to exert a varying amount of firing force.

Consequently, a significant need exists for an improved articulationmechanism for a surgical instrument mechanism that provides enhancedsupport to a firing bar through the articulation joint.

As mentioned above, as used in the art and as used herein, transversemovement of a medical end effector relative to an instrument shaft isconventionally referred to as “articulation.” In prior art medicaldevices having articulation control, the articulation movement isdirected actively from the device handle. This active control can bemechanical and/or electrical. For example, some prior art devices havelevers at the top of the control handle and, when pivoted left the endeffector articulates left and when pivoted right the end effectorarticulates right. Some operate with opposite movement. To effect thisarticulation, it is very difficult for the operator to use only onehand. Thus, often, the operator must hold the handle with one hand andpivot the articulation lever with the other hand. As is known, the trendfor laparoscopic and other similar medical devices is to make themoperable with a single hand because surgeons often lose control of thedevice held in the second hand when it is necessary to remove theirsecond hand from that device in order to operate the articulation lever.Loss of device control is undesirable and extends the surgical procedureif the device falls outside the view of the operating surgeon. One priorart device uses electrical measures to actively control articulation. InU.S. Pat. No. 7,213,736 to Wales et al., electrical power is supplied toan electrically actuated polymer to articulate the end effector activelyin the desired direction. These prior art devices can be characterizedby referring to them as “active articulation” devices, in which anarticulation control device is present on the handle and extends throughthe articulation joint to force the articulation in either articulationdirection. In other words, the forces required to perform articulationare generated internally in the device.

Thus, a significant need also exists for an improved articulationmechanism for a surgical instrument mechanism that is operable with onlya single hand. The articulation assembly of the present invention has nomechanical control device in the handle to effect direct control ofarticulating movement of the end effector. There is no articulationcontrol device present on the handle that extends through thearticulation joint to force the end effector to articulate in adirection. Instead, articulation of the end effector is dependent uponpressure between a surface of the environment in which the end effectorexists and an exterior surface of the end effector, for example, at alocation distal of the articulation joint. A torque to pivot theinventive end effector about the articulation axis arises from forcesexternal to the device. One force is present by the user holding thehandle. The other force acts distal of the articulation joint andimparted by the environment in which the end effector is present andagainst which the end effector is being held. In other words, the forcesrequired to perform articulation are external to the device. This motioncan be referred to herein as “passive articulation” and the“articulation joint” of the present invention operates with passivearticulation—it requires a torque external to the device to articulatethe end effector about the axis of the passive articulation joint.

BRIEF SUMMARY OF THE INVENTION

It is accordingly an object of the invention to provide a surgicalstapling and cutting device that overcomes the hereinafore-mentioneddisadvantages of the heretofore-known devices of this general type.

With the foregoing and other objects in view, there is provided, inaccordance with the invention, a medical device, comprising apistol-shaped handle, a laparoscopic shaft extending from the handlehaving a distal end and defining a shaft axis, a surgical end effectorconnected to the distal end of the shaft, a surgical procedure actuatoroperable to carry out a surgical procedure on tissue at the endeffector, and a rotating knob at the handle that is rotatable withrespect to the shaft about the shaft axis and is operable to actuate thesurgical procedure actuator and effect the surgical procedure.

In accordance with a further mode of the invention, the rotating knob isoperable to actuate the surgical procedure actuator and effect thesurgical procedure when moved in a direction towards the handle.

In accordance with an added mode of the invention, the end effector isconnected to the distal end of the shaft with a passive articulatingconnection.

In accordance with an additional mode of the invention, the end effectoris connected to the distal end of the shaft with a passive articulatingconnection, the surgical procedure actuator is a locking device of thepassive articulating connection, and actuation of the surgical procedureactuator by movement of the rotating knob towards the handle unlocks thepassive articulating connection.

In accordance with yet another mode of the invention, the pistol-shapedhandle has a stapler-closing device, and the end effector is a surgicalstapling end effector having a pair of opposing stapling surfaces,whereby at least one of the stapling surfaces is operable to move withrespect to the other of the stapling surfaces upon actuation of thestapler-closing device to apply a compressive force to tissuetherebetween.

In accordance with yet a further mode of the invention, the end effectorfurther comprises a knife assembly disposed to cut tissue at the endeffector.

In accordance with yet an added mode of the invention, the end effectorcomprises one of a circular surgical staple head and a linear surgicalstaple head.

In accordance with yet an additional mode of the invention, the endeffector is rotationally fixedly connected to the shaft with the passivearticulating connection, and the rotating knob is operable tocorrespondingly rotate the shaft and the end effector when rotated aboutthe shaft axis.

In accordance with again another mode of the invention, the end effectoris rotationally fixedly connected to the shaft, and the rotating knob isoperable to correspondingly rotate the shaft and the end effector whenrotated about the shaft axis.

In accordance with again a further mode of the invention, the rotatingknob is operable to correspondingly rotate the shaft and the endeffector when rotated about the shaft axis and simultaneously actuatethe surgical procedure actuator.

In accordance with again an added mode of the invention, the surgicalprocedure actuator has an unactuated state and an actuated state, thepassive articulating connection has a locked articulation state and anunlocked articulation state, and the surgical procedure actuator changesthe passive articulating connection from the locked articulation stateto the unlocked articulation state when the rotating knob is movedtowards the handle and changes the passive articulating connection fromthe unlocked articulation state to the locked articulation state whenthe rotating knob is released after movement towards the handle hasoccurred.

In accordance with again an additional mode of the invention, the endeffector articulates after the surgical procedure actuator is actuatedby movement of the rotating knob towards the handle, and thereafter, anexternal force is applied to the end effector.

In accordance with still another mode of the invention, when thesurgical procedure actuator is actuated by movement of the rotating knobtowards the handle, the end effector freely articulates dependent uponexternal forces acting upon the end effector.

In accordance with still a further mode of the invention, the endeffector is a surgical stapling end effector having a stapling devicewith staples and a cutting device with a blade, the handle has a staplerclosing actuator closing the stapling device when actuated and a firingactuator that, when actuated staples with the stapling device and cutswith the cutting device, and the stapler closing actuator and the staplefiring actuator are different from the rotating knob.

In accordance with a concomitant mode of the invention, the shaft has afirst longitudinal axis, the end effector has a second longitudinalaxis, at least one of the shaft, the end effector, and the passivearticulating connection has an alignment device, and the alignmentdevice is operable to bias the end effector to substantially align thefirst and second longitudinal axes when the surgical procedure actuatoris actuated by movement of the rotating knob towards the handle.

In accordance with a further concomitant mode of the invention, thealignment device is a center-biasing device.

With the foregoing and other objects in view, there is also provided, inaccordance with the invention, a medical device, comprising apistol-shaped handle, a laparoscopic shaft extending from the handlehaving a distal end and defining a shaft axis, a surgical end effectorconnected to the distal end of the shaft, a surgical procedure actuatoroperable to carry out a surgical procedure on tissue at the endeffector, and a rotating knob at the handle that is rotatable withrespect to the shaft about the shaft axis and is operable to actuate thesurgical procedure actuator and effect the surgical procedure when movedin a direction towards the handle.

Additional advantages and other features characteristic of the presentinvention will be set forth in the detailed description which followsand may be apparent from the detailed description or may be learned bypractice of exemplary embodiments of the present invention. Still otheradvantages of the present invention may be realized by any of theinstrumentalities, methods, or combinations particularly pointed out inthe claims.

Although the invention is illustrated and described herein as embodiedin a surgical stapling and cutting device and methods of use thereof, itis, nevertheless, not intended to be limited to the details shownbecause various modifications and structural changes may be made thereinwithout departing from the spirit of the invention and within the scopeand range of equivalents of the claims. Additionally, well-knownelements of exemplary embodiments of the invention will not be describedin detail or will be omitted so as not to obscure the relevant detailsof the invention.

Other features that are considered as characteristic for the presentinvention are set forth in the appended claims. As required, detailedembodiments of the present invention are disclosed herein; however, itis to be understood that the disclosed embodiments are merely exemplaryof the invention, which can be embodied in various forms. Therefore,specific structural and functional details disclosed herein are not tobe interpreted as limiting, but merely as a basis for the claims and asa representative basis for teaching one of ordinary skill in the art tovariously employ the present invention in virtually any appropriatelydetailed structure. Further, the terms and phrases used herein are notintended to be limiting, but rather, to provide an understandabledescription of the invention. While the specification concludes withclaims defining the features of the invention that are regarded asnovel, it is believed that the present invention will be betterunderstood from a consideration of the following description inconjunction with the drawing figures, in which like reference numeralsare carried forward.

BRIEF DESCRIPTION OF THE DRAWINGS

Advantages of embodiments the present invention will be apparent fromthe following detailed description of the preferred embodiments thereof,which description should be considered in conjunction with theaccompanying drawings in which:

FIG. 1 is an enlarged, fragmentary, perspective view of a firstembodiment of a distal stapling and cutting end effector and a portionof a shaft connected thereto according to the invention viewed from adistal end thereof with a staple cartridge approximately pulled outhalf-way from a staple cartridge jaw of the end effector and with ananvil of the stapler separated from a staple-actuating andtissue-cutting slide;

FIG. 2 is an enlarged, fragmentary, side elevational view of the endeffector of FIG. 1 with the distal cowling, the proximal castellationaxial movement part, and the cartridge removed for clarity, and with theanvil of the stapler connected to the slide;

FIG. 3 is an enlarged, fragmentary, perspective view of the end effectorof FIG. 1 with the staple-actuating and tissue-cutting slide in a distalposition but with the anvil of the stapler separated from the slide;

FIG. 4 is an enlarged, fragmentary, perspective view of the end effectorof FIG. 1 with the staple cartridge removed from the lower jaw/staplecartridge holder and with the clevis rotated in an approximately 45degree angle with respect to center;

FIG. 5 is an enlarged, fragmentary, wireframe side elevational view of adistal portion of the end effector of FIG. 1;

FIG. 6 is an enlarged, fragmentary, wireframe perspective view of acastellation axial movement assembly of the end effector of FIG. 1rotated approximately 90 degrees and with an end effector lateralmovement locking pin and a proximal screw removed for clarity;

FIG. 7 is an enlarged, fragmentary, wireframe perspective view of theend effector of FIG. 6 viewed from a bottom thereof with an end effectorlateral movement locking pin engaging a tooth of the lateral movementsprocket, and with springs and the proximal screw removed for clarity;

FIG. 8 is an enlarged, fragmentary, wireframe bottom plan view of theend effector of FIG. 7 with an end effector lateral movement locking pinengaging a tooth of the lateral movement sprocket;

FIG. 9 is an enlarged, fragmentary, longitudinal cross-sectional view ofthe end effector of FIG. 8 viewed from a bottom thereof with the endeffector lateral movement locking pin engaging a tooth of the lateralmovement sprocket and with the springs removed for clarity;

FIG. 10 is an enlarged, fragmentary, perspective view of the endeffector of FIG. 2 rotated about the longitudinal axis with the clevis,the screw, and the distal castellation sleeve axial movement and springparts removed for clarity;

FIG. 11 is an enlarged, fragmentary, bottom plan view of a distalportion of the end effector of FIG. 1 with the staple-actuating andtissue-cutting slide in a proximal position;

FIG. 12 is an enlarged, fragmentary, bottom plan view of the distalportion of the end effector of FIG. 11 with the staple-actuating andtissue-cutting slide in an intermediate position;

FIG. 13 is an enlarged, fragmentary, radially cross-sectional viewthrough the stapling actuating and tissue-cutting slide of the endeffector of FIG. 2;

FIG. 14 is an enlarged, fragmentary, horizontal longitudinalcross-sectional view through a lower half of the end effector of FIG. 1;

FIG. 15 is an enlarged, fragmentary, horizontal longitudinalcross-sectional view through an upper half of a proximal portion of theend effector of FIG. 1;

FIG. 16 is an enlarged, fragmentary, vertical longitudinalcross-sectional view approximately through a longitudinal axis of aproximal portion of the end effector of FIG. 1;

FIG. 17 is an enlarged, fragmentary, vertical longitudinalcross-sectional view through a right half of the proximal portion of theend effector of FIG. 1;

FIG. 18 is an illustration of a left side of the surgical stapleraccording to the invention with the jaws of the end effector open in anat-rest position of an actuator handle;

FIG. 19 is an illustration of a left side of the surgical stapler ofFIG. 18 with the jaws of the end effector closed in an actuated positionof a thumb trigger of the actuator handle;

FIG. 20 is an illustration of a left side from above the surgicalstapler of FIG. 18 with the lateral movement trigger depressed, with thedistal end effector in a laterally free movement stateposition-dependent upon contact with the environment, such as a surface,and with the jaws of the end effector open in the at-rest position ofthe actuator handle and laterally positioned at an approximately 45degree angle;

FIG. 21 is an illustration of a left side from above the surgicalstapler of FIG. 18 with the lateral movement trigger in an at-reststate, with the distal end effector in a laterally captured movementstate, and with the jaws of the end effector open in the at-restposition of the actuator handle and laterally positioned at anapproximately 30 degree angle;

FIG. 22 is a fragmentary illustration of a left side of the end effectorof FIG. 18 with the jaws open in the at-rest position and laterallypositioned at an approximately 75 degree angle;

FIG. 23 is a fragmentary illustration of a left side of the end effectorof the stapler of

FIG. 18 with the jaws open in the at-rest position and in a rotatedfirst axial position;

FIG. 24 is a fragmentary illustration of a left side of the end effectorof FIG. 23 with the jaws open in the at-rest position and in a normalposition rotated counter-clockwise with respect to FIG. 23;

FIG. 25 is a perspective view from a distal end of a second embodimentof a surgical stapling device according to the invention with aremovable end effector having a self-contained stapling motor, with thestapling jaws in an at-rest open position and at a right lateralposition of approximately 45 degrees, with the ball release lever in anat-rest ball-capture position, and with the motor actuator button in anat-rest motor-off position;

FIG. 26 is an enlarged, perspective view of the removable end effectorof FIG. 25 with the jaws in an at-rest open position and with the slideremoved for clarity;

FIG. 27 is a perspective view from a distal end of a third embodiment ofa surgical stapling device according to the invention with a removableend effector having two ball-connection ends and a self-containedstapling motor, with the stapling jaws in an at-rest open position andat a right lateral position of approximately 45 degrees with staple jawsreversed and facing proximally, with the ball release lever in anactuated ball-released position, and with the motor actuator button inan at-rest motor-off position;

FIG. 28 is an enlarged, perspective view of the removable end effectorof FIG. 27 viewed from a right side and a distal end thereof with thejaws in an at-rest open position and with the slide removed for clarity;

FIG. 29 is a fragmentary, enlarged side cross-sectional wireframe viewof a distal-most end of an actuating handle of the surgical stapling andcutting device of FIGS. 25 and 26 and of a ball-joint of the removablestapling end effector of FIGS. 25 and 26 in a captured and alignedstate;

FIG. 30 is a fragmentary, enlarged side cross-sectional view of adistal-most end of opposite side of the actuating of FIG. 29 with theball-joint in an un-aligned and released state but still captured inbetween clamps of the actuating handle;

FIG. 31 is a perspective view from a proximal end of the stapling andcutting device according to the invention with an anvil removed;

FIG. 32 is a fragmentary, perspective view from a proximal end of thedevice of FIG. 31 with the handle removed to show a proximal portion ofan articulation release device with a pushrod therein;

FIG. 33 is an illustration an enlarged, exploded view of parts of theproximal end of an inner tube of the device of FIG. 31;

FIG. 34 is a fragmentary, perspective view from a distal end of interiorparts connecting the articulation release device to the articulationjoint of the end effector with an outer tube removed;

FIG. 35 is a fragmentary, enlarged, vertically longitudinalcross-sectional view of the parts of FIG. 34;

FIG. 36 is a fragmentary, enlarged, perspective view of a knife guideassembly of the device of FIG. 31 from proximal of a knife guide todistal of a knife blade with outer and inner tubes removed;

FIG. 37 is a fragmentary, enlarged, vertically longitudinalcross-sectional view of a portion of the parts of FIG. 35 at a proximalend of a pullband;

FIG. 38 is a fragmentary, enlarged, vertically longitudinalcross-sectional view of a portion of the parts of FIG. 35 at a distalend of the pullband;

FIG. 39 is a fragmentary, enlarged, side elevational view of a staplerassembly, a drum sleeve, the articulation joint, and a clevis of thedevice of FIG. 31 with an anvil in an open position;

FIG. 40 is a fragmentary, enlarged, side elevational view of the staplerassembly, the drum sleeve, the articulation joint, and the clevis of thedevice of FIG. 31 moved distally with respect to FIG. 39 and with theanvil in a closed, firing position;

FIG. 41 is a fragmentary, enlarged, perspective view of a knife guidesub-assembly from proximal of the knife guide to the knife blade withthe knife guide, the clevis, the left hammock, the drum sleeve, and thecartridge holder removed;

FIG. 42 is a fragmentary, enlarged, vertically transversecross-sectional view of the knife-pushrod pin joint of the device ofFIG. 31;

FIG. 43 is a fragmentary, enlarged, vertically transversecross-sectional view of the pullband-aluminum tube pin joint of thedevice of FIG. 31;

FIG. 44 is a fragmentary, enlarged, vertically transversecross-sectional view of a proximal face of the clevis of the device ofFIG. 31;

FIG. 45 is a fragmentary, enlarged, vertically transversecross-sectional view of plunger pin spring pockets and an articulationrelease pin of the device of FIG. 31;

FIG. 46 is a fragmentary, enlarged, vertically transversecross-sectional view of a plunger pin cam surface and an articulationlocking sprocket of the device of FIG. 31;

FIG. 47 is a fragmentary, enlarged, vertically transversecross-sectional view of the end effector articulation joint of thedevice of FIG. 31;

FIG. 48 is a fragmentary, enlarged, vertically transversecross-sectional view of a distal pullband pin joint of the device ofFIG. 31;

FIG. 49 is a fragmentary, enlarged, vertically transversecross-sectional view of an anvil/upper jaw pivot slot of the device ofFIG. 31;

FIG. 50 is a fragmentary, enlarged, horizontally longitudinalcross-sectional view of the articulation joint portion of the device ofFIG. 31 through spring rods;

FIG. 51 is an illustration of a test bed for knife guiding blades andhammocks of the device of FIG. 31;

FIG. 52 is a fragmentary, enlarged, horizontally longitudinalcross-sectional view of the articulation joint portion of the device ofFIG. 31 through an articulation lock release slide;

FIG. 53 is an exploded perspective view of distal components of thedevice of FIG. 31 viewed from the distal end thereof and without theanvil;

FIG. 54 is a perspective view of an articulating distal portion of afourth embodiment of the end effector according to the invention withthe inner and outer tubes removed;

FIG. 55 is a fragmentary, enlarged, and exploded perspective view of anarticulating portion of the end effector of FIG. 54 rotated with the topinward towards the viewer with the outer tube removed;

FIG. 56 is a fragmentary, enlarged, bottom plan view of the articulatingportion of the end effector of FIG. 54 with the lower clevis and theclosure ring removed;

FIG. 57 is a fragmentary, horizontally longitudinal, cross-sectionalview of the articulating portion of the end effector of FIG. 54 througha lower end of the dogbone guide;

FIG. 58 is a fragmentary, vertically longitudinal, cross-sectional viewof the articulating portion of the end effector of FIG. 54 through thespring rods with the inner tube and the pushrod-blade support removed;

FIG. 59 is a fragmentary, vertically transverse, cross-sectional view ofthe articulating portion of the end effector of FIG. 54 through a distalend of the dogbone guide;

FIG. 60 is a fragmentary, vertically transverse, cross-sectional view ofthe articulating portion of the end effector of FIG. 54 through aproximal end of a dogbone guide chamber of the lower clevis with thedogbone guide removed;

FIG. 61 is a fragmentary, horizontally longitudinal, cross-sectionalview of the articulating portion of the end effector of FIG. 54 througha low intermediate portion of the dogbone guide;

FIG. 62 is a fragmentary, horizontally longitudinal, cross-sectionalview of the articulating portion of the end effector of FIG. 54 througha high intermediate portion of the dogbone guide;

FIG. 63 is a fragmentary, vertically longitudinal, cross-sectional viewof the articulating portion of the end effector of FIG. 54 through aspring rod with the inner tube, the pushrod-blade support, an anvil, anda near half of the staple sled removed;

FIG. 64 is a fragmentary, vertically longitudinal, cross-sectional viewof the articulating portion of the end effector of FIG. 54 through thedogbone guide with a spring plate, the anvil, and the near half of thestaple sled removed;

FIG. 65 is a fragmentary, vertically longitudinal, cross-sectional viewof a distal end of the articulating portion of the end effector of FIG.54 with the inner tube, the pushrod-blade support, the anvil, theclosure ring, and the near half of the staple sled removed;

FIG. 66 is a perspective view of the lower clevis, the lower dogboneclevis, the dogbone guide, and three adjacent knife blades of the endeffector of FIG. 54;

FIG. 67 is a fragmentary, wireframe, vertically transversecross-sectional view of the end effector of FIG. 54;

FIG. 68 is a fragmentary, wireframe, perspective view of an alternativeembodiment of a distal connection of the pullbands of the end effectorof FIG. 54;

FIG. 69 is a fragmentary, vertically transverse cross-sectional view ofthe distal connection of FIG. 68; and

FIG. 70 is a fragmentary perspective view from below of a portion of thedistal connection of FIG. 68.

DETAILED DESCRIPTION OF THE INVENTION

As required, detailed embodiments of the present invention are disclosedherein; however, it is to be understood that the disclosed embodimentsare merely exemplary of the invention, which can be embodied in variousforms. Therefore, specific structural and functional details disclosedherein are not to be interpreted as limiting, but merely as a basis forthe claims and as a representative basis for teaching one skilled in theart to variously employ the present invention in virtually anyappropriately detailed structure. Further, the terms and phrases usedherein are not intended to be limiting; but rather, to provide anunderstandable description of the invention. While the specificationconcludes with claims defining the features of the invention that areregarded as novel, it is believed that the invention will be betterunderstood from a consideration of the following description inconjunction with the drawing figures, in which like reference numeralsare carried forward. The figures of the drawings are not drawn to scale.

Alternate embodiments may be devised without departing from the spiritor the scope of the invention. Additionally, well-known elements ofexemplary embodiments of the invention will not be described in detailor will be omitted so as not to obscure the relevant details of theinvention.

Before the present invention is disclosed and described, it is to beunderstood that the terminology used herein is for the purpose ofdescribing particular embodiments only and is not intended to belimiting. The terms “a” or “an,” as used herein, are defined as one ormore than one. The term “plurality,” as used herein, is defined as twoor more than two. The term “another,” as used herein, is defined as atleast a second or more. The terms “including” and/or “having,” as usedherein, are defined as comprising (i.e., open language). The term“coupled,” as used herein, is defined as connected, although notnecessarily directly, and not necessarily mechanically.

Referring now to the figures of the drawings in detail and first,particularly to FIG. 1 thereof, there is shown a first exemplaryembodiment of a stapling and cutting end effector 1 according to thepresent invention. The major parts of the end effector 1 include aclevis 10, an anvil 20, a cartridge holder 30 for receiving a staplecartridge 100, an adapter sleeve 40, and a lateral translation orarticulation device 50. FIG. 1 illustrates the removability of thestaple cartridge 100 from the cartridge holder 30.

Connecting the anvil 20 to the cartridge holder 30 and the staplecartridge 100 is a staple-actuating and tissue-cutting slide 60. Thisslide 60 operative engages both the anvil 20 and the cartridge holder 30to keep the two parts 20, 30 in proper alignment so that the actuatedstaples inside the cartridge 100 hit their respective stapler anvilswithin the anvil 20 and secure the staples around tissue disposedbetween the anvil 20 and the cartridge 100. The distal facing surface ofthe slide 60 contains a blade 62 for cutting the tissue disposed in thejaws 20, 30 as the tissue is being stapled together. Proximal movementof the slide is shown, diagrammatically, in FIGS. 1 to 3. So that theslide 60 can be seen in FIGS. 1 and 3, the anvil 20 is uncoupled fromthe top end of the slide 60. In operation, however, the slide 60 must becoupled to the anvil 20 as shown in FIG. 2 and, especially, in FIG. 13.

FIG. 2 illustrates the end effector 1 with the adapter sleeve 40 removedto make visible various features of the translation therein.

A first of two primary parts of the lateral translation device 50 areapparent in FIGS. 1 to 3. A proximal part 52 includes a proximalsprocket 522, an intermediate castellated connector 524, and a distalrod 526. In the exemplary embodiment, the intermediate castellatedconnector 524 has four distally projecting teeth 5242, clearly shown inFIG. 2.

Also visible in FIG. 2 is a pull cable adapter 70. The pull cableadapter 70 is connected to a pull cable 110 (dashed lines) at a proximalside and to the cartridge holder 30 at a distal side thereof. The pullcable adapter 70, therefore, is used to pull or push the cartridgeholder 30 with respect to the anvil 20 and, thereby, pivot the anvil 20from an open position to a closed position, or vice-versa, dependentupon movement of the cartridge holder 30. The proximal end of the anvil20 has a cam follower 22 on either side thereof. The proximal end of thecartridge holder 30 defines two cam surfaces 32 on either side thereofand aligned to receive a respective one of the cam followers 22.Accordingly, movement of the cartridge holder in a distal or proximaldirection results in a corresponding opening or closing pivotingmovement of the anvil 20.

FIG. 4 shows the lateral articulating movement of the stapler 20, 30with respect to the clevis 10.

In FIGS. 5 to 8, all parts, including the adapter sleeve 40 and theclevis 10 are shown in wire frame, thereby, revealing features therein.The clevis 10 contains four lumens, two of which are shown in FIG. 5 andall four are shown in FIGS. 6 and 7. A first 12 of the lumens is formedto contain a non-illustrated shaft for controlling distal and proximalmovement of an end effector lateral movement locking pin 120, which pin120 is first shown in FIGS. 8 and 9. The two lateral lumens 14 areshaped to receive the pull-wire that moves the pull cable adapter 70proximally (distal movement of the pull cable adapter 70 is caused by aspring). The other of the two lumens 14 is extra and can receive anynumber of possible additional instrumentation. The drive cable lumen 16is the last of the four lumens and is shaped to receive the flexibledrive cable that turns the drive screw 34 (see FIG. 1), which controlsmovement of the slide 60.

At the distal end of the drive cable lumen 16, the clevis 20 defines anoblong cavity 18 for receiving therein the lateral movement locking pin120. FIGS. 6 to 9, in particular, show an exemplary shape of this cavity18. Because the lateral movement locking pin 120 is oblong incircumferential shape, the pin 120 does not rotate away from an alignedposition with the teeth of the sprocket 522.

Also visible under the top side of the clevis 10 in FIG. 5 are twocentering springs 130. These springs 130 are also shown in FIGS. 6 to 9and, in particular, FIG. 10. To prevent undesired interaction betweenthe springs 130, a dividing plate 140 is sandwiched between the springs130. FIG. 10 illustrates the two springs 130 with the dividing plate 140therebetween.

The features underneath the transparent sleeve 40 are better explainedwith respect to FIGS. 7 to 10. The sleeve 40 defines two exteriorstructures and two internal bores. The first exterior structure is aproximal cylinder 42. The proximal cylinder 42 defines castellations 422at a proximal end thereof. These castellations 422 match and interactwith the intermediate castellated connector 524 of the proximal part 52.The proximal cylinder 42 also defines a first bore 44 that is shaped toreceive the distal rod 526 of the proximal part 52. There is acylindrical, tubular radial clearance between the rod 526 and theinterior surface of the first bore 44 and a longitudinal clearancebetween the proximal end of the cable adapter 70 and the proximal insidesurface of the first bore 44. This tubular-shaped clearance can receivea first tubular biasing device (e.g., a coil spring), which is notillustrated for clarity. The first biasing device is positioned to applya proximally directed force on the proximal-most end of the adaptersleeve 40. In such a configuration, the force applied by the firstbiasing device presses the distal castellations 422 towards and againstthe proximal castellations 5242.

The second exterior structure of the sleeve 40 is a distal cylinder 46.The distal cylinder 46 defines a second bore 48 that is shaped toreceive therein the pull cable adapter 70. The pull cable adapter 70also defines an interior bore 72 that is shaped to receive the distalrod 526 of the proximal part 52. For clarity in the figures, the rod 526is shown extending entirely into the interior bore 72 only by the dashedlines in FIG. 9. In operation, the rod 526 extends entirely into theinterior bore 72. The interior bore 72 is coaxial and, in an exemplaryembodiment, has the same interior diameter of the first bore 44.Accordingly, there exists a cylindrical, tubular radial clearancebetween the rod 526 and the interior surface of the interior bore 72 anda longitudinal clearance between the distal surface of the cable adapter70 and the inside distal surface of the interior bore 72 . This isbecause it is also shaped to house a second tubular biasing device(e.g., a coiled spring), also not illustrated for clarity. The secondbiasing device is provided to impart a distally directed biasing forceagainst the pull cable adapter 70. Such a force keeps the jaws 20, 30 inan open position. Accordingly, the jaws 20, 30 have an at- rest openposition.

Without providing an intermediate part, the two non-illustrated biasingdevices connect and, therefore, form a single spring. However, it isdesirable to not have the two biasing devices interact becauseseparation of the castellated parts causes an unwanted force to beapplied to the cartridge holder 30 and movement of the cartridge holder30 may loosen the connection of the castellated parts. Accordingly, anon-illustrated washer is disposed between the two biasing devices inthe cylindrical cavity 74 defined by the proximal end surface of thepull cable adapter 70 and the distal end surface of the second bore 48.FIG. 7 particularly illustrates the proximal side for holding thiswasher, which is shaped to only receive the distal rod 526 therethrough.Accordingly, because the washer is trapped between the pull cableadapter 70 and the sleeve 40, the two springs are decoupled and providetheir respective biasing forces independent of one another.

The underside view of FIGS. 11 and 12 illustrate the drive shaft 34 ofthe slide 60 and the proximal idler bushing 36 that holds the driveshaft 34 in place within the cartridge holder 30. At the position of theidler bushing 36, the drive shaft 34 does not have threads. However,distal to the idler bushing 36, the drive shaft 34 has threads (whichare not illustrated) extending towards the distal end of the drive shaft34. FIGS. 11 and 12 do not show the thrust bearing 38 on the oppositeend of the drive shaft 34, but FIG. 1 clearly illustrates this bearing38. Also illustrated in FIGS. 11, 12, and 13 is the bottom of the slide60 in the form of a drive nut 64. In an exemplary embodiment, this drivenut 64 is a part that is separate from the blade 62 of the slide 60 butis fixedly connected at the bottom of the blade 62. The illustratedshape of the drive nut 64 has a dumbbell-shaped cross-section to relievesome of the forces exerted upon the threads. In FIG. 11, the drive nut64 is in a proximal position where the anvil 20 is in an openedposition. FIGS. 12 and 13, in contrast, show the drive nut 64 inintermediate positions where the anvil 20 is in a partially closedposition.

FIG. 13 is especially useful in illustrating the shape and configurationof the slide 60, including the blade 62 and the drive nut 64.

The horizontal cross-section along approximately the longitudinal axisof the end effector in FIGS. 14 and 15 is particularly useful in viewingthe bores around the distal rod 526. Again, for clarity, the rod 526 isnot shown extending all the way to the distal surface of the bore 72 inthe pull cable adapter 70 even though it does extend all the way to thissurface. Around the proximal end of the rod 526 is the first bore 44 inthe adapter sleeve 46. Just distal of the first bore 44 is the cavity 74for receiving the washer therein and, just distal of the cavity 74, isthe interior bore 72 of the pull cable adapter 70 for receiving thesecond biasing device.

The vertical cross-section along approximately the longitudinal axis ofthe end effector in FIG. 16 is particularly useful in viewing theconnection between the drive nut 64 and the drive shaft 34. Again, forclarity, the rod 526 is not shown extending all the way to the proximalsurface of the bore 72 in the pull cable adapter 70.

The vertical cross-section along approximately the longitudinal axis ofthe end effector in FIG. 17 is particularly useful in viewing theconnection between the slide 60 and both the anvil 20 and the cartridgeholder 30. Two upper wings 66 are disposed in a groove inside the anvil20 and two lower wings 68 form an upper holding surface of the I-shapeformed by the lower wings 68 and the drive nut 64.

FIGS. 18 to 24 are illustrations of the entire longitudinal extent ofthe stapling device according to the invention with the distal endeffector 1 and a first exemplary embodiment of the actuating handle 2.As shown in FIG. 60, the jaws 20, 30 are at rest in an open position.

The thumb trigger is connected to the proximal end of the pull cablethat ends at the pull cable adapter 70. Thus, when the thumb trigger 3is actuated (see FIG. 19), the cartridge holder 30 is pulled in aproximal direction. Due to the shape of the cam surfaces 32, the camfollowers 22 are caused to move and, thereby, pivot the anvil 20approximately into its stapling position. As set forth above, it is notthe thumb trigger 3 that insures correct parallel orientation of theanvil 20 with respect to the cartridge holder 30 and, thereby, thestaple cartridge 100. Rather, it is the slide 60 that insures the properparallel orientation.

FIGS. 20 to 22 illustrate how the end effector 1 is passivelyarticulated in a lateral direction. When the index finger trigger 4 isdepressed, the lateral movement locking pin 120 is moved rearward todisengage from the sprocket 522. If no force is applied to the endeffector 1, then, due to the two centering springs 130, the end effector1 remains in the axial aligned orientation shown in FIGS. 18 and 19.However, when an external force is applied to the end effector 1 (asshown in FIG. 20), the laterally free end effector 1 can be moved aboutthe axis of the sprocket 522 into any position, e.g., an approximately45 degree left position shown in FIG. 20, or into any other orientation.See, e.g., FIG. 22. When the index finger trigger 4 is released, thelateral movement is prevented by returning the distal end of the lockingpin 120 in between two teeth of the sprocket 522. Thus, as shown forexample in FIGS. 21 and 22, the end effector can be locked into asignificant number of laterally articulated positions. It is noted thatthe staple cartridge 100 is not illustrated in FIGS. 18 to 24 forclarity.

FIGS. 23 and 24 illustrate the axial rotational control of the endeffector. Such axial control is provided by the two respectivecastellated features 422, 5242 of the adapter sleeve 40 and the lateraltranslation device 50, respectively. In FIG. 23, the castellations areengaged and the anvil is in the 90 degree position with respect to thehandle. To disengage the castellations, a force sufficient to overcomethe first biasing device is exerted on the end effector 1 and thecastellation features 422, 5242 separate. Then, the end effector 1 canbe rotated clockwise or counter-clockwise. FIG. 68 shows, for example,the anvil 20 rotated counter-clockwise into an approximately 9 o'clockposition.

FIGS. 1 to 3 can be used to illustrate the operation of the motorizedstapling function of the stapling device of the present invention. InFIG. 1, the slide 60 is in a proximal position. A reversible motor ishoused inside the handle. A three-way switch is connected to the motor.When in a middle position, for example, the motor is off. When in aproximal position, the motor is turned on and will rotate the driveshaft 34 so that the slide 60 moves in a proximal direction. Incontrast, when the switch is in a distal position, the motor is turnedon and will rotate the drive shaft 34 so that the slide 60 moves in adistal direction. Of course, the switch can be merely a two-way switchwithout an off position.

FIGS. 25 and 26 illustrate a second exemplary embodiment of the staplingand cutting system 200 according to the invention. This system 200 isdifferent than the first embodiment in that the motorized staplingassembly is entirely contained in the end effector 210. Therefore, thehandle 220 only needs to have two actuating devices. The first actuatingdevice 222 is a ball joint releasing lever and the second actuatingdevice is the stapling/cutting motor on/off button 224.

The end effector 210 is connected to the distal end of the actuationshaft 226 of the handle 220 at a ball-joint connector 228. The endeffector 210 has, at its distal-most end, a ball joint 212. The balljoint 212 has two opposing cup-shaped clamps 2122, 2124. The interiorsurfaces of the clamps 2122, 2124 are shaped to correspond to the outershape of the ball joint 212. The clamps 2122, 2124 translate towards oraway from one another based upon an actuation of the lever 222.

The clamps 2122, 2124 are biased towards one another in a closedposition such that, when the ball joint 212 is disposed therein, the twoclamps 2122, 2124 tightly grip the ball joint 212. Actuation of thelever 222 causes the clamps 2122, 2124 to separate and, thereby, allowthe ball joint 212 to rotate freely in between the two clamps 2122,2124. Thus, when the lever 222 is actuated, the end effector 210 is“free” to move based upon pressure against structures in theenvironment, such as tissue near a stapling/cutting site. The lever 222can be pushed down sufficiently far to allow the ball joint 212 to moveentirely out of the clamps 2122, 2124. Therefore, if a first endeffector 210 is clamped at a first site and a second end effector 210 isdesired to clasp and cut a second site, the first end effector 210 canbe left clamped at the first site, the shaft 226 can be removed from thebody and loaded with a second end effector 210, and the second endeffector 210 can be guided to the second site.

The second actuating device 224 is needed when the user desires toeffect the stapling and cutting with the end effector 210. When the endeffector 210 is at the desired position for stapling/cutting, theactuator 224 (e.g., button) is depressed. This actuation, preferably,completes (or interrupts) a circuit that connects power to the motorinside the end effector 210, thereby causing the slide 60 to movedistally and effect the stapling and cutting functions of the jaws.

FIG. 25 illustrates the complete freedom for orienting the end effector210 in any position with respect to the ball joint 212. In FIG. 25, theend effector 210 is shown in a right lateral orientation ofapproximately 45 degrees and with an anvil orientation of approximately90 degrees.

FIGS. 27 and 28 illustrate a variation of the second embodiment of theend effector shown in FIGS. 25 and 26. In particular, the handle 220 isthe same as in FIGS. 25 and 26. However, the end effector 310 isdifferent. Specifically, the end effector 310 has a proximal ball joint312 similar to the ball joint 212 in FIGS. 25 and 26, but also has asecond, distal ball joint 314, having a shape virtually identical to theproximal ball joint 312. Therefore, when the lever 222 is pressed downto release the ball joint 312, 314, the end effector 310 can be allowedto rest within the body and the opposite end can be grasped between theclamps 2122, 2124. In such an orientation, shown in FIG. 27, thestapling/cutting can be actuated when the jaw opening is facing theuser.

It is also noted that placement of an end effector 210, 310 at asurgical site sometimes requires the access to the surgical site to berather small in comparison to the opened jaws of the end effector 210,310. With the ability to reverse the end effector 310, somedifficult-to-reach sites may be accessed that are not reachable with thesingle ball joint end effector 210.

FIGS. 29 and 30 show the clamps 2122, 2124 at the distal-most end of theactuating shaft 226 of the surgical stapling and cutting device 200, 300of FIGS. 25 to 28 holding a ball-joint 212, 312, 314 of the end effector210, 310 of FIGS. 25 to 28. These figures illustrate that the lever 222is connected to a push rod 230 having at its distal end a plunger 232.This plunger 232 has a cup-shaped surface 234 at its distal-most endwith a shape corresponding to the outer shape of the ball joint 212,312, 314. Thus, when the plunger 232 is in its distal-most position incontact with the ball joint 212, 312, 314, the ball is captured and doesnot move or rotate. In contrast, when the plunger 232 is movedproximally as shown in FIG. 30, the ball of the ball joint 212, 312, 314is free to rotate between the clamps 2122, 2124.

The endostapler illustrated in FIGS. 31 to 70 add various differentalternative and/or additional features to the endostapler illustrated inFIGS. 1 to 30.

In all of FIGS. 31 to 70, the top jaw or anvil 1020 is only shown inFIGS. 39 and 40 for the sake of clarity. Further, the anvil 20 isdescribed above in detail with regard to FIGS. 1 to 30 and, therefore,any repetitive description is avoided hereinafter.

The exemplary handle shown in FIG. 31 is manufactured by EthiconEndo-Surgery, Inc., and can be found, for example, on Ethicon's linearcutter model ECHELON 60 Endopath Stapler. Description of this handle is,therefore, believed to be redundant as parts and functional descriptionsof this handle are published in the art. Such description is herebyincorporated herein by reference in its entirety.

As set forth above, the distal end of the endostapler of the presentinvention is configured to house a standard staple cartridge 100. Thiscartridge 100, too, is described in prior publications and does not needto be repeated here. The publications are, therefore, herebyincorporated herein by reference in their entireties.

FIG. 31 illustrates portions of an alternative embodiment of theendostapler 1000 of the present invention. It is noted that two distalactuation levers on the handle 1200 of the endostapler 1000 are hiddenfrom view in FIG. 31 for the sake of clarity.

The distal end of the handle 1200 includes a bell-shaped actuator 1100,which provides two degrees of control for the articulating portions ofthe endostapler 1000. First, the bell actuator 1100 freely rotates aboutthe central axis of the endostapler 1000 on distal end of the handle1200. Because the bell actuator 1100 is rotationally fixedly connectedto the outer tube 1110, when the bell actuator 1100 is rotated clockwiseor counterclockwise, the entire distal end of the endostapler 1000rotates correspondingly. Second, the bell actuator 1100 can be displacedover a given distance in a proximal direction on the distal end of thehandle 1200. As will be described below in further detail, proximaldisplacement of the bell actuator 1100 causes a corresponding movementof the articulation lock release slide 120, 1120 to allow the distal endeffector 1002 to articulate at the translation device 50, 1050. Anon-illustrated bias device (i.e., a compression spring) located, forexample, in the distal portion of the bell actuator 1100 is used to biasthe bell actuator 1100 and the articulation lock release slide 1120 in adistal direction so that the articulation lock release slide 120, 1120remains in the actuated or locked position while the bell actuator 1100is in an un-actuated state. See, i.e., FIGS. 8 and 9. This bias deviceis housed inside the bell actuator 1100 but is not shown in FIG. 32 forclarity. Also not shown is a snap ring that fits into a groove 1139around the inner tube 1130. The bias device is delimited on the proximalside of the rod pullblock 1105 (see FIG. 34) and the distal side of thesnap ring. In such a configuration, when the bell actuator 1100 ispulled proximally, the actuator 1100 forces the rod pullblock 1105proximally to, thereby, move the articulation lock release slide 120,1120 into an unlocked position. A keyhole on the interior surface of thebell actuator 1100 form-lockingly surrounds the rod pullblock 1105 sothat rotation of bell actuator 1100 about the longitudinal axis of theinner tube 1130 forces the rod pullblock 1105 into a correspondingrotation. A form-locking or form-fitting connection is one that connectstwo elements together due to the shape of the elements themselves, asopposed to a force-locking connection, which locks the elements togetherby force external to the elements. As such, the inner tube and theentire distal assemblies of the device 1000 rotates as well. In analternative configuration, the longitudinal movement of the bellactuator 1100 can function similar to a standard ball point pen by afirst actuation placing the slide 120, 1120 in an unlocked state and asecond actuation placing the slide 120, 1120 in a locked state.

With the bell actuator 1100 of the present invention, a physician isable to operate every function of the endostapler 1000 with one hand.

FIG. 32 illustrates the proximal end of the endostapler 1000 without thehandle 1200. Coaxially disposed inside the bell actuator 1100 is apushrod 1102 that will be used to move the cutting blade 1060 when thestapler is in the firing orientation.

FIG. 33 is an illustration of the parts at the proximal end ofendostapler 1000 that axially fixedly and rotationally freely connectthe distal assembly to the bell actuator 1100. More specifically, aninner tube 1130 (to be disposed inside the outer tube 1110) has aproximal extension 1132 defining an inner tube coupling chamber 1134. Aclam-shell bushing 1131 has a length substantially equal to theextension 1132 of the inner tube 1130 and a bushing coupling chamber1133 corresponding to the coupling chamber 1134 of the proximalextension 1132. A rotational couple 1141 has a distal T-shaped rotationlink 1143 having an outer shape corresponding to both of the couplingchambers 1133 and 1134 so that, when the link 1143 is disposed betweenthe extension 1132 and the bushing 1131, the link 1143 is free to rotatetherein. This couple 1141 is fixed inside the handle 1200 through aproximal port 1145 on a proximal end of the couple 1141.

When placed together, the inner tube 1130 is axially held with respectto the couple 1141 but is rotationally independent of the couple 1141.Because the three coupling parts 1130, 1131, 1141 are sized to fitinside the outer tube 1110, when the parts are placed inside the outertube 1110, the outer tube 1110 becomes a form-locking connection thatprevents any separation of the inner tube 1130 and the bushing 1131 (solong as the outer tube 1110 sufficiently covers this area). Thus, whenthe bell actuator 1100 is rotated about the longitudinal axis of theinner tube 1130, the inner and outer tubes 1110, 1130 are able to rotateabout the coaxial axis of the tubes 1110, 1130 but remain longitudinallystable with respect to the couple 1141, which is longitudinally fixedinside the handle 1200.

FIG. 34 illustrates the proximal end of the endostapler 1000 without thehandle 1200, the bell actuator 1100, and the outer tube 1110. As can beseen, the inner tube 1130 is hollow and receives therethrough thepushrod 1102, which will be described in further detail below. Alsoshown in these figures are the clevis 1010 and the drum sleeve 1040,which, together, form the articulating connection or joint 1050 of theendostapler 1000.

It is noted at this point that the lower jaw/staple cartridge holder1030 is longitudinally fixed with respect to the handle 1200. Thisfixation contrasts with the upper anvil 1020, which can be pivoted andbe moved somewhat longitudinally when sliding through the keyhole shapedcam surfaces 32 to close and/or open the jaws (described in furtherdetail below/above with respect to cam surfaces 1032).

To form the longitudinally fixed connection of the staple cartridgeholder 1030 and the handle 1200, the inner tube 1130 must be connectedto the staple cartridge holder 1030. But, at the same time, the staplecartridge holder 1030 must be able to articulate with respect to thelongitudinal extent of the inner tube 1130. Thus, an axially fixed butlaterally articulating connection must exist between the two parts 1030,1130.

To provide such a connection, the present invention includes at leastone pullband 1140, shown, for example, in FIGS. 35 to 38. In anexemplary configuration, multiple pullbands 1140 are provided, one nextto the other. Three or four bands form two possible configurations. Withtwo pullbands 1140 as opposed to one, the longitudinal strength remainsapproximately the same but the force needed to laterally bend thepullbands 1140 is reduced. The same is true for three or four pullbands1140. FIG. 37 illustrates the proximal end of the pullband 1140, whichis longitudinally pinned to the distal end of the inner tube 1130 with aproximal pullband pin 1142. To provide a strong connection between thepullband 1140 and the inner tube 1130, a proximal guide block 1150, forexample, made of brass, is disposed between the distal end of the innertube 1130 and the pullband 1140.

The pullband 1140 spans the entire extent of the articulation joint1050, as shown in FIG. 35, and is connected, as shown in FIG. 38, to adistal guide block 1160. The distal guide block 1160 (also, e.g., madeof brass) has at least one projection that fits into at least one recesson the proximal end of the staple cartridge holder 1030. Later figuresillustrate the measures by which the distal guide block 1160 isconnected to the staple cartridge holder 1030 so that, finally, thestaple cartridge holder 1030 is axially fixedly connected to the handle1200 while being able to articulate with respect to the inner tube 1130.As shown in FIG. 38, a distal pullband pin 1144 axially locks the distalend of the pullband 1140 to the distal guide block 1160.

A first embodiment of jaw 20, 30 movement is described in the textabove. There, the staple cartridge 30 moves axially and the anvil 20 isrelatively stationary. In the configuration of the endostapler 1000shown in FIGS. 31 et seq., movement is operationally opposite.

Noting that the staple cartridge holder 1030 is longitudinally fixedwith respect to the handle 1200, there still must be an assembly thatpermits closure of the two jaws 20, 30; 1020, 1030. Closure is,therefore, accomplished by movement of the upper jaw/anvil 1020 as setforth in the following text.

A first of the two levers of the handle 1200 (e.g., a proximal handle)is operatively connected to the outer tube 1110 to move the outer tube1110 distally when the first lever is compressed/actuated. Because theclevis 1010, the articulation joint 1050, and the drum sleeve 1040 areaxially fixedly connected to the outer tube 1110 (and because the outertube 1110 can slide longitudinally along the inner tube 1130), anactuation of the first lever moves the drum sleeve 1040 distally.

FIG. 39 illustrates the anvil 1020 in an open state. As can be seentherein, a gap 1031 exists between the distal end of the drum sleeve1040 and a proximal shelf at the bottom of the staple cartridge holder1030. In such an orientation, the drum sleeve 1040, the clevis 1010, andthe outer tube 1110 are proximally disposed at a distance from theshelf.

FIG. 40 illustrates the anvil 1020 in a closed state. As can be seentherein, no gap 1031 exists between the distal end of the drum sleeve1040 and the proximal shelf of the staple cartridge holder 1030. In suchan orientation, the drum sleeve 1040, the clevis 1010, and the outertube 1110 are in a position where the drum sleeve 1040 contacts theshelf.

In contrast to the axially fixed position of the staple cartridge holder1030 with respect to the handle 1200, and similar to the movement of thedrum sleeve 1040, the knife 60, 1060 must translate with respect to thehandle 1200 along the longitudinal axis. FIGS. 35, 36, and 38 to 41illustrate the axially displaceable connection of the knife 1060 to theknife-moving features of the handle 1200.

With regard to FIG. 35, a pushrod 1102 extends from the handle 1200 andis connected to a second non-illustrated lever (e.g., a distal lever) ofthe handle 1200. The distal end of the pushrod 1102 is connected to atleast one flexible knife blade 1062 through a pushrod pin 1122. Thedistal end of the knife blade 1062 is connected to the proximal side ofthe cutting blade 1060 such that the cutting blade 1060 moves distallyor proximally to follow corresponding movement of the pushrod 1102. Itis noted that the knife blade 1062 has a proximal, upwardly extendingflange 1064 that houses a bore for receiving the pushrod pin 1122. Thisoff-axis connection between the pushrod 1102 and the knife blade 1062causes the distal end of the knife blade 1062 to be forced downwardlywhen pushed in the distal direction and, therefore, to stay in positioninside a pushrod-blade support 1070 shown, for example, in FIGS. 36 and42.

The knife blade 1062 is flexible enough to bend in any way that thearticulation joint 1050 bends. Therefore, the knife blade 1062 is alsoflexible enough to possibly kink if it was not supported. The presentinvention, therefore, provides a pushrod-blade support 1070, which isshown in FIGS. 36 and 42. Therein, the proximal end of the pushrod-bladesupport 1070 clearly reveals the rectangular blade channel 1072 forsupporting slidably the rectangular knife blade 1062. Also shown thereinis a curved pushrod channel 1074 for supporting slidably the curved(e.g., cylindrical) exterior of the pushrod 1102. Thus, thepushrod-blade support 1070 supports the pushrod 1102 at locations wherethe pushrod 1102 is inside the support 1070 and also supports the knifeblade 1062 where the knife blade 1062 is inside the support 1070.

FIG. 36 shows the connection of the support 1070 and its relation to theproximal guide block 1150.

Like the pullbands 1140, more than one knife blade 1062 can be next toone another. In such a configuration, the multiple blades 1062 have thesame longitudinal stiffness but provide greater flexibility when thereis a bend in the articulation joint 1050.

Revealed in FIG. 41 is the articulation lock release slide 1120 thatlocks the articulation of the jaws 1020, 1030.

FIGS. 42 to 50 illustrate a vertical cross-section of the tube portiondistal of the handle 1200 along planes that are orthogonal to thelongitudinal axis of the endostapler 1000.

FIG. 42 shows the cross-section of the connection junction of the knifeblade 1062 and the pushrod pin 1122. The pushrod pin 1122 passes throughthe entirety of two adjacent blades 1062 and the pushrod 1102 but doesnot extend outside the pushrod's outer surface. This figure alsoillustrates the relationship of the inner and outer tubes 1130, 1110 andthe pushrod-blade support 1070. Also apparent in this figure is anunlock pullrod 1104 used for unlocking the lock release slide 1120. Thelongitudinal extent of the unlock pullrod 1104 is first shown in FIG. 35and is also shown in FIGS. 36, 37, 41, and 52 and 53. Most particularly,with exterior parts hidden, FIG. 41 shows how the pullrod 1104 connectsthe bell actuator 1100 to the articulation lock release slide 1120. Withthe distal end of the pullrod 1104 passed through and wrapped around thedistal end of the articulation lock release slide 1120 as shown in FIG.37, the unlock pullrod 1104 establishes a longitudinally fixedconnection between the bell actuator 1100 and the articulation lockrelease slide 1120. As such, when the bell actuator 1100 is movedproximally, the articulation lock release slide 1120 moves in acorresponding proximal direction to separate the distal teeth 1121 ofthe articulation lock release slide 1120 and the spokes 1041 of thesprocket 1522. See, in particular, FIGS. 46 and 52. It is noted that thewrapped connection between the pullrod 1104 and the articulation lockrelease slide 1120 is only an exemplary embodiment. Other form-lockingor force-locking connections are possible as well.

FIG. 43 shows the connection through the pullband 1140 and inner tube1130 pin joint. As set forth above, the proximal pullband pin 1142passes entirely through the blades 1062, the proximal guide block 1150,and the inner tube 1130 but not through the outer tube 1110.

FIG. 44 shows the area immediately proximal of the proximal end of thearticulation lock release slide 1120. In this exemplary embodiment, twopullbands 1140 are disposed above two blades 1062. To provide support toat least one of the pullbands 1140 and the blades 1062, a pair ofhammocks 1066 is placed along sides of the articulating portions of thepullbands 1140 and blades 1062. Each of the hammocks 1066 has a U-shape(along a longitudinal cross-section) so that the proximal arm of eachhammock 1066 bends around the proximal surface of the clevis 1010 andthe distal arm of each hammock 1066 bends around a catching surfacewithin the drum sleeve 1040, as shown in FIG. 50, for example.

Inside the clevis 1010 are disposed two spring rods 1012 about which arerespective spring rod collars 1014, the function of which is to biaslaterally the entire assembly distal of the articulation joint 1050towards and along the longitudinal axis. The spring rods and collars1012, 1014 will be described in further detail below.

FIG. 45 illustrates the open area in the center of the articulation lockrelease slide 1120 that receives the bend portion of the pullrod 1104(not illustrated in this figure). Also shown are the cavities 1016 inwhich the non-illustrated bias springs of the spring rods 1012 rest.This cross-sectional area also includes portions of the two pullbands1140 disposed above the two knife blades 1062.

FIG. 46 illustrates the open area in which the distal end of spring rods1012 acts against cam surfaces 1018. It is noted that the cam surfaces1018 are arcuate in shape so that contact between the spring rods 1012and the cam surfaces 1018 always act in an axial direction normal to thesurface at the distal-most end of the spring rods 1012. See, forexample, FIG. 56. In such a configuration, the force that is applied bythe spring rods 1012 against the cam surfaces 1018 to bias the distalarticulating assembly (e.g., anvil 1020, staple cartridge holder 1030,drum sleeve 1040) towards the longitudinal axis of the inner and outertubes 1130, 1110 is always at the same radius about the articulationaxis of the articulating staple cartridge holder 1030. One advantage ofsuch a configuration lies in the fact that the spring rods 1012 are notforced laterally in any way, in which case, the distal-most end of thespring rods 1012 could catch and lock on the cam surface 1018.

FIG. 47 illustrates, in cross-section, the area within the endostaplerarticulation joint 1050. Again, this area includes portions of the twopullbands 1140, of the two blades 1062, and of the two hammocks 1066.Upper and lower axle pucks 1152 are inserted in orifices 1042 above andbelow on surfaces of the drum sleeve 1040. Connection of the clevis 1010to the drum sleeve 1040 at the articulation joint 1050 is symmetrical onthe top and bottom. The pucks 1152 are inserted into the orifices 1042in the top and bottom of the proximal end of the drum sleeve 1040. Inthis orientation, the assembly is inserted into the distal end of theclevis 1040 to align screw holes 1011 with center threaded bores 1153 ofthe pucks 1152. When aligned, screws 1013 are threaded respectively intothe pucks 1152 to axially secure the drum sleeve 1040 into the clevis1010 while allowing the drum sleeve 1040 to articulate about the axisdefined by the longitudinal axis of the two screws 1013.

FIG. 48 illustrates the area of the distal pullband pin joint. In thisarea, the distal ends of the pullbands 1140 are secured by the distalpullband pin 1144 disposed inside the bore of the distal guide block1160. The distal guide block 1160 is disposed in the staple cartridgeholder 1030 and secured thereto as set forth above.

FIG. 49 illustrates the area just proximal of the cutting blade 1060 andthe fixed connection of the two knife blades 1062 inside a proximalorifice of the cutting blade 1060. This view also clearly shows the camsurfaces 1032 that allow the anvil 1020 to pivot and translate withrespect to the staple cartridge holder 1030.

FIG. 50 shows a longitudinal cross-section through the spring rods 1012.Visible in this view is the entire longitudinal extent of the hammocks1066. The distal sections of the hammocks 1066 articulate about avertical axis near the distal end of the hammocks 1066. In FIG. 50,there exists a substantial gap between the spring rods 1012 and thehammocks 1066. If the hammocks 1066 were not present, there exists thepossibility that the thin knife blades 1062 could bend and warp or kinkinto these gaps. By placing the hammocks 1066 therebetween, anypossibility of impermissible bending of the knife blades 1062 isprevented. FIG. 51 is provided to show the extreme bending extent of thehammocks 1066 and the blades 1062 therebetween in a test bed made forsuch a purpose. It is noted that the upper hammock 1066 is not utilizedin an upward bend with respect to FIG. 51 because it tracks the insidesurface of the curve at the critical bending area. In contrast, thelower hammock 1066 is utilized to substantially prevent the knife blades1062 therebetween (two in this exemplary embodiment) from impermissiblybending into the gap of the test bed. Because each hammock 1066 is heldrigidly at either end and is made out of a substantially non-elasticmaterial (e.g., of stainless steel), it forms a sling or “hammock” thatsupports the bent knife blade(s) 1062 therebetween.

FIG. 52 illustrates a cross-section through the articulation lockrelease slide 1120 and clearly shows the distal connection bend of theunlock pullrod 1104 inside the slide 1120. In such a configuration,proximal displacement of the unlock pullrod 1104 causes a correspondingproximal displacement of the slide 1120 to unlock the teeth 1121 of theslide 1120 from between the corresponding teeth 1041 on the proximalside of the drum sleeve 1040. A distal bias is imparted upon thearticulation lock release slide 1120 by a non-illustrated bias devicethat resides in a hollow 1123 and presses against the distal end of thehollow 1123 and a block 1124 that is fixed with respect to the clevis1010.

FIG. 35 shows the connection between the unlock pullrod 1104 and thehandle 1200. A rod pullblock 1105 has a longitudinal bore 1107 forreceiving therein the pullrod 1104. The rod pullblock 1105 also hastransverse bores 1109 for receiving non-illustrated set screws thereinfor securing the pullrod 1104 inside the rod pullblock 1105. An interiorportion of the bell actuator 1100 is shaped to engage the rod pullblock1105 (for example, in a form-fitting connection such as a keyhole) anddisplace the rod pullblock 1105 proximally when the bell actuator 1100is moved proximally.

FIG. 53 is an exploded perspective view of the distal parts of theendostapler as viewed from the distal end thereof.

It is noted that the clevis 1010 in FIGS. 34 to 53 is a one-piece part.Alternatively, the clevis 1010 can be molded in two halves. In such acase, the pucks 1152 can be eliminated and, instead, form parts of eachof the two clevis halves, thereby eliminating the need for the screws1013 because the outer tube 1110 will hold the two halves together whenattached to the proximal end of the clevis 1010. Such a configuration isillustrated in the endostapler embodiment of FIGS. 54 et seq.

FIG. 54 shows some internal parts of this fourth embodiment of the endeffector. The anvil 1020 is disposed opposite the staple cartridgeholder 1030 and a closure ring 1040 surrounds the proximal end of thestaple cartridge holder 1030. The inner and outer tubes 1130, 1110 areremoved so that the articulation lock release slide 1120, the pushrod1102, and the pushrod-blade support 1070 can be seen clearly. A screendoor 1103 is mounted around the pushrod 1102 and inside the inner andouter tubes 1130, 1110 and the bell actuator 1100. The handle 1200 andbell actuator 1100 are removed for clarity. The screen door 1103restricts movement of the pushrod 1102 to only one direction -- distal-- because the knife/cutting blade 1060 only moves in the distaldirection.

The two-part clevis is best illustrated in the views of FIGS. 55 and 56.These figures show various internal features of the end effector of FIG.54 with the outer tube 1110 removed. In the exploded view of FIG. 55,connection of the pullband(s) 1140 to the staple cartridge holder 1030is apparent. A non-illustrated pin (see also FIG. 59) passes through afirst proximal flange of the holder 1030, a first spacer 1170, a distalflange of the pullband 1140, a second spacer 1170, and a second opposingproximal flange of the holder 1030, respectively. The closure ring 1040,as shown in FIG. 59, holds the pin therein to provide the longitudinalconnection of these components.

Various features of the knife/cutting blade 1060 are also revealed inFIG. 55. The blade 1060 has a proximal recess 1061 for connecting adistal end of the knife blade 1062 thereto. In the exemplary embodiment,the recess 1061 and distal end form a keyhole-shaped lock. The upperhalf of the blade 1060 has two opposing guide wings 1063 having anexterior shape that fits into a corresponding groove inside the bottomsurface of the upper anvil 1020. The lower half of the blade 1060 alsohas two opposing guide wings 1065. The holder 1030 has a groove insidethe top surface thereof for receiving the lower wings 1065 therein.These two pairs of wings 1063, 1065 ensure that the anvil 1020 and theholder 1030 are at a fixed parallel position when the blade 1060 istraversing there along in the cutting and stapling process. Alsodisposed on the lower half of the blade 1060 is a proximally extendingflange 1067. A plate spring 1090 is attached to the staple cartridgeholder 1030 by rivets 1036. The plate spring 1090 and other features ofthe blade 1060 will be described in greater detail below.

FIGS. 55 and 56 also show various portions of the two-part clevis 2010,2020. As can be seen in FIGS. 56 and 58, the interior surface of theupper clevis half 2010 defines two cavities 2011 that each house arespective spring rod 1012 and the non-illustrated bias device for thatspring rod 1012. In the exemplary embodiment shown, the upper clevishalf 2010 defines the entire cavity 2011 for the spring rods 1012 andthe lower clevis half 2020 defines the bottom cavity portion 2021 foraccommodating only the bias device. The clevis halves 2010, 2020 alsodefine articulation ports 2012, 2022 for receiving therein articulationbosses 2031, 2041 on each of the two dogbone clevis parts 2030, 2040.

FIGS. 56 and 57 illustrate the longitudinal connectivity of the featureswithin the outer tube 1110. The pushrod-blade support 1070 is disposedinside a lower channel of the inner tube 1130. This pushrod-bladesupport 1070 also has a distal extension 1071 with a narrow proximalneck 1074 and a relatively wider distal head 1075. With a correspondingrecess 2023 in the bottom of the lower clevis half 2020, the distalextension 1071 can be longitudinally fixed to the clevis half 2020 and,therefore, the remainder of the clevis.

The outer tube 1110 and the lower clevis half 2020 are removed in FIG.56 to illustrate the configuration of the spring rods 1012 inside thespring rod cavities 2011. Again, the spring rod bias devices (e.g., coilsprings) are not shown in the cavities 2011 for clarity. With variousparts removed, the articulating extent of the pullbands 1140 is clearlyshown in FIG. 56. The supporting surfaces for the pullbands 1140 insidethe upper clevis half 2010 are visible at the cross-section plane ofFIG. 58. The upper dogbone clevis 2030 has two opposing supportingsurfaces 2032 each at a similar acute angle with respect to thecenterline of the un-articulated pullbands 1140 Likewise, the upperclevis half 2010 has two opposing supporting surfaces 2013 each at anacute angle with respect to the centerline of the un-articulatedpullbands 1140.

The opposite viewing direction towards the interior of the lower clevishalf 2020 is illustrated in FIGS. 55 and 58. The articulation sectionfor the knife blades 1062 is illustrated along with the supportingsurfaces 2042 for the dogbone 1080 inside the lower dogbone clevis 2040and the supporting surfaces 2024 for the dogbone 1080 inside the lowerclevis half 2010. Also visible in this orientation are guiding andsupporting surfaces for the dogbone guide 1080. In FIG. 57, it is seenthat the lower dogbone clevis has a kidney-shaped distal dogbonedepression 2043 and the lower clevis half 2010 has a kidney-shapedproximal dogbone depression 2025. These depressions 2025, 2043 andsurfaces 2024, 2042 are also illustrated in FIG. 66 and will bedescribed in detail below. A further feature visible in FIGS. 59, 62,and 66 is the interior passage of the dogbone guide 1080 having left andright surfaces 1082 and will be describe in further detail below.

The distal end of the dogbone guide 1080 is shown in the verticalcross-section of FIG. 59. The distal dogbone depression 2043 houses thedistal end of the dogbone guide 1080 and, when unarticulated, thedogbone guide 1080 does not touch the supporting surfaces 2042 of thelower dogbone clevis 2040.

The proximal housing for the distal end of the dogbone guide 1080 isillustrated in FIG. 60. To better reveal the features of the proximaldogbone depression 2025, the dogbone guide 1080 is removed from thesefigures.

Both of the depressions 2025, 2043 with the lower extending portions ofthe dogbone guide 1080 disposed therein are shown in horizontal,longitudinally transverse cross-section of FIG. 57. Also shown thereinare the lower features of the pushrod-blade support 1070, the cuttingblade 1060, and the staple sled 102 (which is a part of the removablestaple cartridge 100). These features are enlarged in FIGS. 61 and 62.

FIGS. 63, 64, and 65 illustrate the knife blade 1060 lock-out feature.In other words, the safety that prevents the knife blade 1060 fromadvancing when there is no staple cartridge 100 or a previously firedstaple cartridge 100 in the staple cartridge holder 1030. For ease ofunderstanding, the only part of the staple cartridge 100 shown in thesefigures is the staple sled 102.

The knife blade 1060 should be allowed to move distally only when thestaple sled 102 is present at the firing-ready position, i.e., when thesled 102 is in the position illustrated in FIG. 65. If the sled 102 isnot present in this position, this can mean one of two things, eitherthere is no staple cartridge 100 in the holder 1030 or the sled 102 hasalready been moved distally—in other words, a partial or full firing hasalready occurred with the loaded staple cartridge 100. Thus, the blade1060 should not be allowed to move, or should be restricted in itsmovement. Accordingly, the sled 102 is provided with a lock-out contactsurface 104 and the blade 1060 is provided with a correspondingly shapedcontact nose 1069. It is noted at this point that, the lower guide wings1065 do not rest against a floor 1034 in the cartridge holder 1030 untilthe blade 1060 has moved distally past an edge 1035. With such aconfiguration, if the sled 102 is not present at the distal end of theblade 1060 to prop up the nose 1069, then the lower guide wings 1065will follow the depression 1037 just proximal of the edge 1035 and,instead of advancing on the floor 1034, will hit the edge 1035 and stopfurther forward movement of the blade 1060. To assist with such contactwhen the sled 102 is not present, the staple cartridge 1030 has a platespring 1090 (attached thereto by rivets 1036). With the plate spring1090 flexed upward and pressing downward against the flange 1067 (atleast until the flange 1067 is distal of the distal end of the platespring 1090), a downwardly directed force is imparted against the blade1060 to press the wings 1065 down into the depression 1037. Thus, as theblade 1060 advances distally without the sled 102 being present, thewings 1065 follow the lower curve of the depression 1037 and are stoppedfrom further distal movement when the distal edge of the wings 1065 hitthe edge 1035. FIG. 63, for example, shows the distal edge 1035 and tworaised bosses 1038 that extend the height of the edge 1035 to insurethat the wings 1065 cannot be forced over the edge 1035 when the sled102 is not present.

FIG. 66 illustrates an exemplary movement of the dogbone 1080 within thelower clevis half 2020 and the lower dogbone clevis 2040. In the fullyleft articulated position of FIG. 66, the distal bottom projection ofthe dogbone 1080 is in a rotated position within the distal dogbonedepression 2043 and the proximal bottom projection is in a rotatedposition within the proximal dogbone depression 2025. Importantly, theleft vertical surface of the dogbone 1080 is almost fully supported onthe left dogbone supporting surfaces 2024, 2042. The shapes of thedepressions 2025, 2043 and the bottom projections of the dogbone 1080are selected such that there is no elongation or compression of thedogbone 1080 but, merely, a rocking left to right when articulation ofthe end effector occurs.

Three side-by-side knife blades 1062 are diagrammatically illustrated inFIG. 66 within a left articulated position of the lower clevis halves2020, 2040. When bent to the left, the knife blades 1062 are pressedagainst the right interior surface 1082 of the dogbone 1080.Accordingly, the interior surfaces 1082 are shaped dependent upon theextent that the end effector will be articulated. Due to the limitationsof drafting the features of the invention, the blades 1062 are onlyshown in a diagrammatic, approximate curved orientation.

To better understand some features of the knife blades 1062, enlargedviews of the proximal connection to the pushrod 1102 and thepushrod-blade support 1070 are shown in FIG. 67. While a configurationhaving co-axially aligned knife blades 1062 and the pushrod 1102 isenvisioned and possible, an offset connection shown, for example, inFIGS. 41 and 67, is used. As set forth above, the length of the knifeblades 1062 make it desirable for the knife blades 1062 to be presseddown fully into the blade channel 1072 within the pushrod-blade support1070. FIG. 41 shows a first embodiment for an offset connection thatbiases the blades 1062 into the channel 1072. FIG. 67 shows a secondembodiment for this offset connection. In this second embodiment, theblades 1062 are not fixedly connected to the pushrod 1102 as in thefirst embodiment (connected by transverse pushrod pin 1122). Instead,the pushrod 1102 is formed with a chamber 1108 into which is insertedthe proximal end of the blades 1062. By forming the chamber 1108 in ashape that axially longitudinally holds the blades 1062 (e.g., with atransverse offset), there is no need for a fixed connection. In thisembodiment, the chamber 1108 is approximately L-shaped in verticalcross-section to provide such a transverse offset, but it can be anynumber of different shapes.

The distal connection of the pullbands 1140 is shown particularly wellin FIG. 59. It is noted that, in such a configuration, left or rightarticulation imparts a bend on each of the two, three, four, or moreadjacent pullbands 1140. Because each pullband 1140 has a fixed length,and because the pullbands 1140 are stacked alongside one another,articulation in a given direction bends each of the pullbands 1140differently, even if the difference is very slight. To compensate forsuch differences in bending, an alternative embodiment of the distalconnection is provided and is shown in FIGS. 68 to 70. For clarity andsimplicity, only a portion of the upper dogbone clevis 2030 is showndiagrammatically in these figures.

This alternative embodiment replaces the spacers 1170 in the firstembodiment. Here, five pullbands 1140 are disposed alongside oneanother. The upper dogbone clevis 2030 defines an interior bore 2033(e.g., a circular bore) into which is inserted a piston 2050 having anexterior shape corresponding to the interior shape of the bore 2033. Thebore 2033 has a proximal window 2034 through which the pullbands 1140project into the bore 2033. The window 2034 has a width approximatelyequal (but just slightly larger than) the total width of the pullbands1140.

The piston 2050 has a transverse bore into which is threaded a proximalpullband pin 2060 that functions as an axle when threaded through thepiston 2050 and through the distal pullband bore 1145 of each of thepullbands 1140. See FIG. 70. The interior 2051 of the piston 2050 doesnot have a shape corresponding to the width of the stacked pullbands1140. Instead, the interior opening for receiving the distal end of thepullbands 1140 has a winged horizontally cross-sectional shape.

As the end effector articulates, the distal end of the pullbands 1140are bent into a curve. When adjacent parallel plates such as thepullbands 1140 are bent together, the outside plates move differentlythan the middle or inner plates. This non-homogeneous movement iscompensated for by the winged opening 2051 and the oval-shaped distalpullband bores 1145. As the end effector is articulated, the bendingforces imparted upon the pullbands 1140 cause the piston 2050 to rotatewithin the bore 2033 of the upper dogbone clevis 2030. The more that theend effector articulates, the more the piston 2050 rotates, until fullarticulation presses the outside pullband 1140 against the inner surfaceof the winged opening 2051. At this point, the proximal ends of eachpullband 1140 are aligned but the distal ends shown in FIGS. 68 to 70are not. The presence of the ovular openings 1145 allow the pullbands1140 to move slightly with respect to one another.

The foregoing description and accompanying drawings illustrate theprinciples, preferred embodiments and modes of operation of theinvention. However, the invention should not be construed as beinglimited to the particular embodiments discussed above. Additionalvariations of the embodiments discussed above will be appreciated bythose skilled in the art.

Therefore, the above-described embodiments should be regarded asillustrative rather than restrictive. Accordingly, it should beappreciated that variations to those embodiments can be made by thoseskilled in the art without departing from the scope of the invention asdefined by the following claims.

1. A medical device, comprising: a pistol-shaped handle; a laparoscopicshaft extending from the handle having a distal end and defining a shaftaxis; a surgical end effector connected to the distal end of the shaft;a surgical procedure actuator operable to carry out a surgical procedureon tissue at the end effector; and a rotating knob at the handle:rotatable with respect to the shaft about the shaft axis; and operableto actuate the surgical procedure actuator and effect the surgicalprocedure.
 2. The medical device according to claim 1, wherein therotating knob is operable to actuate the surgical procedure actuator andeffect the surgical procedure when moved in a direction towards thehandle.
 3. The medical device according to claim 1, wherein the endeffector is connected to the distal end of the shaft with a passivearticulating connection.
 4. The medical device according to claim 2,wherein: the end effector is connected to the distal end of the shaftwith a passive articulating connection; the surgical procedure actuatoris a locking device of the passive articulating connection; andactuation of the surgical procedure actuator by movement of the rotatingknob towards the handle unlocks the passive articulating connection. 5.The medical device according to claim 1, wherein: the pistol-shapedhandle has a stapler-closing device; and the end effector is a surgicalstapling end effector having a pair of opposing stapling surfaces, atleast one of the stapling surfaces being operable to move with respectto the other of the stapling surfaces upon actuation of thestapler-closing device to apply a compressive force to tissuetherebetween.
 6. The medical device according to claim 1, wherein theend effector further comprises a knife assembly disposed to cut tissueat the end effector.
 7. The medical device according to claim 1, whereinthe end effector comprises one of a circular surgical staple head and alinear surgical staple head.
 8. The medical device according to claim 3,wherein: the end effector is rotationally fixedly connected to the shaftwith the passive articulating connection; and the rotating knob isoperable to correspondingly rotate the shaft and the end effector whenrotated about the shaft axis.
 9. The medical device according to claim1, wherein: the end effector is rotationally fixedly connected to theshaft; and the rotating knob is operable to correspondingly rotate theshaft and the end effector when rotated about the shaft axis.
 10. Themedical device according to claim 9, wherein the rotating knob isoperable to correspondingly rotate the shaft and the end effector whenrotated about the shaft axis and simultaneously actuate the surgicalprocedure actuator.
 11. The medical device according to claim 4,wherein: the surgical procedure actuator has an unactuated state and anactuated state; the passive articulating connection has a lockedarticulation state and an unlocked articulation state; and the surgicalprocedure actuator: changes the passive articulating connection from thelocked articulation state to the unlocked articulation state when therotating knob is moved towards the handle; and changes the passivearticulating connection from the unlocked articulation state to thelocked articulation state when the rotating knob is released aftermovement towards the handle has occurred.
 12. The medical deviceaccording to claim 4, wherein the end effector articulates after: thesurgical procedure actuator is actuated by movement of the rotating knobtowards the handle; and thereafter, an external force is applied to theend effector.
 13. The medical device according to claim 4, wherein, whenthe surgical procedure actuator is actuated by movement of the rotatingknob towards the handle, the end effector freely articulates dependentupon external forces acting upon the end effector.
 14. The medicaldevice according to claim 1, wherein: the end effector is a surgicalstapling end effector having a stapling device with staples and acutting device with a blade; the handle has: a stapler closing actuatorclosing the stapling device when actuated; and a firing actuator that,when actuated: staples with the stapling device; and cuts with thecutting device; and the stapler closing actuator and the staple firingactuator are different from the rotating knob.
 15. The medical deviceaccording to claim 4, wherein: the shaft has a first longitudinal axis;the end effector has a second longitudinal axis; at least one of theshaft, the end effector, and the passive articulating connection has analignment device; and the alignment device is operable to bias the endeffector to substantially align the first and second longitudinal axeswhen the surgical procedure actuator is actuated by movement of therotating knob towards the handle.
 16. The medical device according toclaim 15, wherein the alignment device is a center- biasing device. 17.A medical device, comprising: a pistol-shaped handle; a laparoscopicshaft extending from the handle having a distal end and defining a shaftaxis; a surgical end effector connected to the distal end of the shaft;a surgical procedure actuator operable to carry out a surgical procedureon tissue at the end effector; and a rotating knob at the handle:rotatable with respect to the shaft about the shaft axis; and operableto actuate the surgical procedure actuator and effect the surgicalprocedure when moved in a direction towards the handle.